[G26-22] Leniolisib (APDS) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V

In accordance with §35a (1) Sentence 11 Social Code Book (SGB) V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. On behalf of the Federal Joint Committee (GBA), IQWiG therefore solely assesses the information on patient numbers and costs in the pharmaceutical company's dossier.